Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors (ELUCIDATE)

April 22, 2026 updated by: Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.

A Phase 1/2 Open-label Multicenter Study to Assess the Safety, Pharmacokinetics, and Anti-tumor Activity of GTAEXS617 in Patients With Advanced Solid Tumors

The primary purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of GTAEXS617 (REC-617) in participants with advanced solid tumors.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A phase 1/2 study to assess the safety, tolerability, pharmacokinetics and anti-tumor activity of GTAEXS617-001 as monotherapy and in combination, in patients with one of the following advanced solid tumors: head and neck squamous cell carcinoma, colorectal adenocarcinoma, pancreatic adenocarcinoma, non-small cell lung cancer, breast cancer (HR+ and HER2- that has progressed to a prior treatment with CD4/CDK6 inhibitor), ovarian epithelial carcinoma.

Study Type

Interventional

Enrollment (Estimated)

230

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Antwerp, Belgium
        • Recruiting
        • GZA Ziekenhuizen - campus Sint-Augustinus
      • Brussels, Belgium
        • Recruiting
        • Institute Jules Bordet
      • Brussels, Belgium
        • Recruiting
        • Clinique Universitaires Saint-Luc
        • Principal Investigator:
          • Rachel Galot
      • Liège, Belgium
        • Recruiting
        • CHU Sart Tilman
        • Principal Investigator:
          • Laurence Lousberg
  • United Kingdom
      • Glasgow, United Kingdom
        • Recruiting
        • The Beatson West of Scotland Cancer Centre
        • Principal Investigator:
          • Jeff Evans
      • London, United Kingdom
        • Recruiting
        • UCL Hospitals NHS Foundation Trust
        • Principal Investigator:
          • Martin Forster
      • Manchester, United Kingdom
        • Recruiting
        • The Christie Nhs Foundation Trust
        • Principal Investigator:
          • Donna Graham
      • Newcastle upon Tyne, United Kingdom
        • Recruiting
        • Newcastle Upon Tyne NHS Foundation Trust
        • Principal Investigator:
          • Elizabeth Ruth Plummer
      • Oxford, United Kingdom
        • Recruiting
        • Oxford University Hospitals NHS Foundation Trust
        • Principal Investigator:
          • Simon Lord
  • United States
    • California
      • Los Angeles, California, United States, 90089
        • Recruiting
        • USC Norris Comprehensive Cancer Center
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Recruiting
        • Start Midwest
    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • START San Antonio
    • Utah
      • West Valley City, Utah, United States, 84119
        • Recruiting
        • START Mountain Region

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Life expectancy > 3 months.
  • One of the following histologically or cytologically confirmed advanced solid tumors: head and neck squamous cell carcinoma (HNSCC), pancreatic adenocarcinoma, non-small cell lung cancer (NSCLC), breast carcinoma (hormone receptor-positive [HR+] and Human Epidermal Growth Receptor 2 negative [HER2-] that has progressed to a prior treatment with Cyclin-Dependent Kinase 4 (CDK4)/ Cyclin-Dependent Kinase 6 [CDK6] inhibitor), or platinum-resistant high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers (HGSOC), or triple negative breast cancer (TNBC).
  • Must have disease that is advanced (ie, surgery or radiotherapy are not considered to be potentially curative), recurrent, or metastatic following SoC treatments.
  • Adequate hematological, liver, and renal function.
  • Must have tumor lesion(s) or metastases amenable to biopsy, excluding bone metastases.

Key Exclusion Criteria:

  • Active and clinically significant (CS) infection.
  • Refractory nausea and/or vomiting, chronic gastrointestinal disease, or previous significant bowel resection, with CS sequelae that would preclude adequate absorption of GTAEXS617.
  • Symptomatic central nervous system (CNS) malignancy or metastases.
  • Concurrent active or previous malignancy.
  • Prior organ or allogeneic stem-cell transplantation.
  • Moderate or severe cardiovascular disease.
  • Received anticancer therapy within 28 days or 5 half-lives (whichever is shorter) before the first dose of the study treatment.
  • Received treatment with known strong/moderate inhibitors and/or strong inducers of cytochrome P450 3A isoform subfamily (CYP3A) within 14 days or 5 half-lives before the first dose of study treatment.
  • Received treatment with known inhibitors or inducers of P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) within 14 days or 5 half-lives before the first dose of study treatment.
  • Received treatment with known substrates of organic anion transporting peptide or BCRP within 14 days or 5 half-lives before the first dose of study treatment.
  • Unresolved or unstable serious toxic side-effects of prior chemotherapy or radiotherapy
  • Has had or is scheduled to have major surgery <28 days prior to the first dose of study treatment.

Note: Other protocol Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 1: Dose Escalation Monotherapy
Participants will receive GTAEXS617 oral tablets in increasing doses.
Drug: GTAEXS617
Administered as specified in the treatment arm.
Other Names:
  • REC-617
Experimental: Phase 1: Dose Escalation Combination Therapy
Participants will receive GTAEXS617 oral tablets in increasing doses in combination with standard of care (SoC) treatment.
Drug: GTAEXS617
Administered as specified in the treatment arm.
Other Names:
  • REC-617
Drug: SoC
Participants will receive selected SoC regimen (fulvestrant, paclitaxel + bevacizumab, pegylated liposomal doxorubicin, or capecitabine) administered as specified in the treatment arm.
Experimental: Phase 2: Dose Expansion Monotherapy
Participants will receive GTAEXS617 oral tablets at Recommended Phase 2 Dose (RP2D).
Drug: GTAEXS617
Administered as specified in the treatment arm.
Other Names:
  • REC-617
Experimental: Phase 2: Dose Expansion Combination Therapy
Participants will receive GTAEXS617 oral tablets at RP2D in combination with SoC treatment.
Drug: GTAEXS617
Administered as specified in the treatment arm.
Other Names:
  • REC-617
Drug: SoC
Participants will receive selected SoC regimen (fulvestrant, paclitaxel + bevacizumab, pegylated liposomal doxorubicin, or capecitabine) administered as specified in the treatment arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame: Up to 2 years
Up to 2 years
Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)
Time Frame: Up to 28 days
Up to 28 days
Phase 2 : Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time Frame: Up to 2 years
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Disease Control Rate (DCR)
Time Frame: Up to 2 years
Up to 2 years
Duration of Response (DOR)
Time Frame: Up to 2 years
Up to 2 years
Progression-Free Survival (PFS)
Time Frame: Up to 2 years
Up to 2 years
Maximum Plasma Concentration (Cmax) of GTAEXS617
Time Frame: Predose up to 24 hours postdose
Predose up to 24 hours postdose
Time Maximum Plasma Concentration (Tmax) of GTAEXS617
Time Frame: Predose up to 24 hours postdose
Predose up to 24 hours postdose
Area under Plasma Concentration Curve From Time Zero to the Last Quantifiable Concentration (AUC0-inf) of GTAEXS617
Time Frame: Predose up to 24 hours postdose
Predose up to 24 hours postdose
Phase 1: ORR as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time Frame: Up to 2 years
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.

Collaborators

GT Apeiron LLC

Investigators

  • Study Director: Medical Director, Exscientia AI Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2023

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

July 25, 2023

First Submitted That Met QC Criteria

August 8, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GTAEXS617-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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